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Record of Telephone Conversation, September 5, 2012 pm - Flucelvax


Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 05-Sep-2012 09:15 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Other -
Telecon Summary:
Need BPL reports with data for the 1.1 method
FDA Participants: Brenda Baldwin, Timothy Fritz, Timothy Nelle, Anissa Cheung, Xianghong Jing
Non-FDA Participants:
Matthew Gollwitzer – Regulatory
Umang Shah -– Regulatory
Manish Vyas – Regulatory
Kerstin Platz – Regulatory
Karsten Kattmann – Site Head, Marburg
Holger Kost – Head of QC
Klaus Dieter-Diehl – Quality Control
Reinhard Wilms – Technology Development
Bjoern Jobst - Technology Development
Stefan Knapp – Head of QA
Manfred Brunen – Technology Transfer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
CBER stated that:
  • The validation approach for TR #294885 is different from the previous validation protocol (#234079) used to validate the removal of BPL for FCC ------(b)(4)------------- produced from the old process 1.0, and
  • The new SOP (293950) for the measurement of residual BPL (process 1.1) for the ------(b)(4)---------- used in the validation study and the assay validation data have not been submitted
NVD committed to provide SOP 293950 and BPL Validation Report (294026 – BPL Process 1.1 – V.03.REP.P141-01).
CBER noted that the ----(b)(4)--------- lots used to determine residual BPL from the 2012/2013 production campaign is not adequate and that NVD would also need to show data from the -----------(b)(4)--. NVD stated that the ------(b)(4)---- is essentially the same since the ---(b)(4)-------- is the only difference ----(b)(4)-----------------. CBER stated that at issue were the differences in the limit-test validation protocol, particularly the change in limit of quantitation from -------(b)(4)-----------------------.  CBER stated that NVD would need to test every US lot of ---(b)(4)---- with the total lots required for testing for the 2012/2013 season and 2013/2014 to be determined by CBER using the BPL ---(b)(4)-----------results. In addition, CBER stated that appropriate specifications for BPL levels need to be proposed and included as information in the package insert.
In a September 18, 2012 e-mail, NVD committed to performing residual BPL testing on all US lots for the 2012/13 season with the validated method as per Report 294026.  The specification on the ---(b)(4)-------- will be not more than (NMT) (b)(4) which is comparable to the US licensed Fluvirin -----(b)(4)---- product.  In parallel a study on BPL -----------(b)(4)------ will be initiated; however, results will not be available prior to the 2012/2013 season.  Based on the outcome of the proposed study and in conjunction with existing supportive data from process 1.0, NVD will propose discontinuing routine testing of BPL at the -----(b)(4)------- stage.  For the 2012 flu season a report with the results will be submitted as an amendment and for the flu season 2013 onwards the results will be reported in the annual strain change update.